Bill · S. 3014· Senate(119-S-3014)
Ensuring Timely Access to Generics Act of 2025
- Introduced
- 10/16/2025
- Last activity
- 10/16/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Jeanne Shaheen
- Cosponsors
- - 1 - 1
- Introduced
- In Committee
What this bill would do
The ``Ensuring Timely Access to Generics Act of 2025'' proposes amendments to the Federal Food, Drug, and Cosmetic Act regarding citizen petitions. The bill aims to change how the Secretary determines if a petition was submitted primarily to delay an application. It introduces several factors for the Secretary to consider when identifying such delay tactics. Additionally, the bill establishes new requirements for submitting petitions before a person can file a civil action. It also sets specific timelines for when a petition must be submitted after a person knows the relevant information. Finally, the bill modifies the rules for how courts should handle the dismissal of certain civil actions.
Yes· 3 of 4
Does this lower the price of prescription medicines?+5
The bill aims to facilitate quicker access to generic drugs by making it harder for petitioners to use delay tactics.
Would households on low incomes be better off under this?+4
By speeding up the availability of generic medications, the bill may reduce healthcare costs for low-income families.
Does this make what the government does easier for the public to see?+3
The bill provides specific factors and potential guidance to help the Secretary identify and disclose delay tactics in citizen petitions.
The opposite
Does this protect the right to fair treatment by the courts?-2
The bill mandates stricter administrative requirements and timelines that could lead to the dismissal of civil actions.
Who it would affect, and how
Potential Positive Impacts for People
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Improved ability to identify delay tactics: The Secretary is given specific factors to consider to determine if a petition was submitted for the primary purpose of delaying an application, such as whether the petition was submitted without relevant data or if it raises issues already addressed in a previous petition (Section 2, amending Section 505(q)(1)(E)).
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Clearer guidelines for petitioners: The Secretary is authorized to issue or update guidance to describe the factors considered in determining if a petition is intended to delay (Section 2, amending Section 505(q)(1)(E)(ii)(I)).
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Requirement for administrative steps before litigation: The bill requires a person to submit a petition to the Secretary before filing a civil action to set aside, delay, or prevent the approval of certain applications (Section 2, amending Section 505(q)(2)(A)).
Potential Negative Impacts for People
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Stricter timelines for petition submission: A petition and any supplements must now be submitted within 180 days after the person knows the information that forms the basis of the request (Section 2, amending Section 505(q)(2)(B)).
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Risk of legal action being dismissed: If a person files a civil action without complying with the new petition requirements or timeliness rules, a court may dismiss the action either without prejudice or with prejudice (Section 2, amending Section 505(q)(2)(D)).
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Potential for dismissal if agency action is not final: A civil action may be dismissed without prejudice if the Secretary has not yet taken final agency action on a timely filed petition (Section 2, amending Section 505(q)(2)(D)(iii)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Low Income Households+4Good For Urban Residents+2
- Healthcare
- Reduces Prescription Drug Costs+5
- Governance And Ideology
- Improves Government Transparency+3Improves Due Process-2
- 10/21/2025
- 1 Cosponsor added.
- 10/16/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Tammy BaldwinDemocrat · Wisconsin
Susan CollinsRepublican · Maine